Pew Letter on New Meaningful Use Objective to Capture Identifiers for Implanted Devices
In the letter, Pew asks the committee to consider how the proposed objective for UDI capture advances several goals of the meaningful use program and addresses feedback previously provided by the Health Information Technology Policy Committee.
Download the letter (PDF)
February 12, 2014
HIT Policy Committee, Meaningful Use Workgroup
Office of the National Coordinator for Health Information Technology
Patriots Plaza III
355 E Street, SW
Washington, DC 20201
RE: A new meaningful use objective to capture identifiers for implanted devices.
Dear Workgroup Members,
We appreciate your ongoing interest in a new meaningful use objective for the capture of unique device identifiers (UDIs) in electronic health records (EHRs). As you commence your review of the proposed objectives, we strongly urge you to retain the objective for the capture of the UDI for implanted devices in your final recommendations.
The Pew Charitable Trusts is an independent, non-profit research and public policy organization. Pew seeks to enhance medical device safety and foster device innovation that benefits patients.
The Food and Drug Administration (FDA) last September finalized regulations establishing the UDI system, which will provide each device with a code corresponding to its make, model and other clinically relevant information, such as expiration date. Manufacturers are preparing to implement this system, and the highest risk devices will have UDIs starting this fall. This UDI system will serve as the cornerstone for significant improvements in medical device safety, but only once it is widely adopted by hospitals and clinicians, including through its integration in EHRs.
The proposed objective for UDI capture advances several goals of the meaningful use program and addresses feedback provided by the Health Information Technology Policy Committee last week:
- Better clinical decision support: The inclusion of UDIs in EHRs will allow both primary care physicians and specialists to make more informed decisions on patient care. Knowing the specific device implanted in patients will allow clinicians to assess whether the patient has a product associated with specific complications or a recalled technology.
- Care coordination: UDI capture in EHRs will enable primary care physicians and specialists to know which devices are implanted in patients, essential to improve care for patients who switch providers or see multiple clinicians.
- Patient engagement: UDI documentation in EHRs will create an accessible data source for patients to take a more active role in their healthcare by providing a clear source of data on the device implanted in their body. Patients could then submit more precise adverse event reports and work with their healthcare providers to track product performance.
The approval of this objective would support the frequent, consistent and accurate documentation of devices used in care, enhancing recall resolution, ensuring more precise adverse event reports and providing primary care providers, specialists, and patients with detailed information on implanted products. Conversely, without this objective, EHR vendors may not develop new fields for UDI, fields that are created may not be interoperable across EHR platforms, and hospitals may continue to exclude detailed information on the specific products implanted in patients.
UDI capture has generated support from several key healthcare stakeholders, including regulators, providers and patient organizations. FDA highlights UDI documentation in electronic health information—including EHRs—as a central pillar to the agency’s vision for improved device postmarket surveillance.
Therefore, to improve care quality and patient safety, we strongly urge the Meaningful Use Workgroup to seize this opportunity to support a new meaningful use objective that would ensure sufficient capture of UDIs for implanted devices.
Should you have any questions or if we can be of assistance, please contact Josh Rising, director of medical devices at The Pew Charitable Trusts, at 202-540-6761 or email@example.com.
Josh Rising, MD
The Pew Charitable Trusts